/ Not yet recruitingNot Applicable [Translation] Study on the bioequivalence of teprenone capsules in healthy volunteers
本试验旨在研究健康受试者单次空腹和餐后口服广东迈德珐医药科技有限公司研制、北京星昊医药股份有限公司生产的替普瑞酮胶囊(50 mg)的药代动力学特征;以卫材(中国)药业有限公司生产的替普瑞酮胶囊(施维舒®,50 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性,并观察两制剂在健康受试者中的安全性。
[Translation] This study aims to study the pharmacokinetic characteristics of teprenone capsules (50 mg) developed by Guangdong Medfa Pharmaceutical Technology Co., Ltd. and produced by Beijing Xinghao Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration in healthy subjects; using teprenone capsules (Servishu®, 50 mg) produced by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation, compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, evaluate the human bioequivalence of the two preparations, and observe the safety of the two preparations in healthy subjects.
100 Clinical Results associated with Guangdong Medfa Pharmaceutical Technology Co., Ltd
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100 Translational Medicine associated with Guangdong Medfa Pharmaceutical Technology Co., Ltd